Psoriasis Clinical Trial
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
Summary
This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.
Eligibility Criteria
Inclusion criteria
Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
Subjects must be deemed by the investigator to benefit from continued secukinumab therapy
Exclusion criteria
Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
Pregnant or nursing (lactating) women
Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU)
Other protocol-defined inclusion/exclusion criteria may apply
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There are 93 Locations for this study
Anniston Alabama, 36207, United States
Mesa Arizona, 85202, United States
Paradise Valley Arizona, 85253, United States
Upland California, 91786, United States
Tamarac Florida, 33321, United States
Eagan Minnesota, 55121, United States
Saint Louis Missouri, 63117, United States
Lincoln Nebraska, 68516, United States
Freehold New Jersey, 07728, United States
Charlotte North Carolina, 28210, United States
Oklahoma City Oklahoma, 73103, United States
Duncansville Pennsylvania, 16635, United States
Charleston South Carolina, 29460, United States
Columbia South Carolina, 29204, United States
Jackson Tennessee, 38305, United States
Benbrook Texas, 76126, United States
Dallas Texas, 75216, United States
Dallas Texas, 75246, United States
Houston Texas, 77074, United States
League City Texas, 77573, United States
Mesquite Texas, 75150, United States
Seattle Washington, 98122, United States
Caba Buenos Aires, C1181, Argentina
Rosario Santa Fe, S2000, Argentina
Buenos Aires , C1417, Argentina
Caba , C1419, Argentina
Cordoba , X5016, Argentina
Córdoba , X5000, Argentina
Maroochydore Queensland, 4558, Australia
Malvern East Victoria, 3145, Australia
Genk , 3600, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Sao Paulo SP, 04023, Brazil
Sao Paulo SP, 04266, Brazil
Sevlievo Gabrovo, 5400, Bulgaria
Pleven , 5800, Bulgaria
Sofia , 1612, Bulgaria
St. John's Newfoundland and Labrador, A1A 5, Canada
St. John's Newfoundland and Labrador, A1C 5, Canada
Newmarket Ontario, L3Y 3, Canada
Waterloo Ontario, N2J 1, Canada
Trois-Rivieres Quebec, G8Z 1, Canada
Bruntal Czech Republic, 792 0, Czechia
Uherske Hradiste Czech Republic, 686 0, Czechia
Zlin Czech Republic, 760 0, Czechia
Aachen , 52064, Germany
Erlangen , 91054, Germany
Erlangen , 91056, Germany
Gommern , 39245, Germany
Hamburg , 22415, Germany
Hildesheim , 31134, Germany
Koeln , 50937, Germany
Leipzig , 04103, Germany
Nürnberg , 90429, Germany
Ratingen , 40878, Germany
Zerbst , 39261, Germany
Ashkelon , 78278, Israel
Haifa , 33394, Israel
Ramat Gan , 52656, Israel
Tel Aviv , 64239, Israel
Catania CT, 95100, Italy
Prato PO, 59100, Italy
Siena SI, 53100, Italy
Verona VR, 37134, Italy
Lipa City Batangas, 4217, Philippines
Dasmarinas Cavite, 4114, Philippines
Manila Metro Manila, 1003, Philippines
Las Pinas , 1740, Philippines
Manila , 1003, Philippines
Manila , 1008, Philippines
Quezon City , 1102, Philippines
Quezon City , 1118, Philippines
Bialystok , 15-35, Poland
Warszawa , 02-34, Poland
Ekaterinburg , 62002, Russian Federation
Ekaterinburg , 62010, Russian Federation
Kemerovo , 65002, Russian Federation
Moscow , 11552, Russian Federation
St Petersburg , 19006, Russian Federation
Yaroslavl , 15000, Russian Federation
Singapore , 11907, Singapore
Singapore , 16960, Singapore
Singapore , 52988, Singapore
Lucenec , 984 0, Slovakia
Khon Kaen THA, 40002, Thailand
Bangkok , 10400, Thailand
Chiang Mai , 50200, Thailand
Leytonstone London, E11 1, United Kingdom
Cannock Staffordshire, WS11 , United Kingdom
Bradford West Yorkshire, BD5 0, United Kingdom
Glasgow , G31 2, United Kingdom
London , SE1 9, United Kingdom
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